Identity
- Trade Name
- AIMTAB KETONE TABLETS FDA UDI
- Generic Name
- Ketone (acetoacetate) IVD, reagent FDA UDI
- Device Name
- Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC. FDA UDI
- Model / Reference
- 13100 FDA UDI
- Description
- Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684131005 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Ketone (acetoacetate) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ketone (acetoacetate) IVD, reagent
Aimtab Ketone Tablets by Germaine Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ketone (acetoacetate) IVD, reagent.
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- keto mojo β-ketone test strips (50pcs/box) — KETO-CHECK, INC. · Class II
- KetoBM — Ketobm LLC · Class I
- KetoSens — i-SENS, Inc. · Class I
- bkt ß-Ketone Test Strips (100 pcs/box) — Adam Lawrence · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI aa4eb819-4337-4400-98ed-2908efd3cd35 33 fields · synced May 30, 2026